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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSIR-SPHERES
Classification Namemicrospheres radionuclide
ApplicantSIRTEX MEDICAL LIMITED
PMA NumberP990065
Date Received10/25/1999
Decision Date03/05/2002
Product Code
NAW[ Registered Establishments with NAW ]
Docket Number 03M-0010
Notice Date 01/23/2003
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for sir-spheres. The device is indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (ihac) of fudr (floxuridine).
Approval Order Approval Order
Supplements: S001 S004 S006 
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